Medical Device QA and RA Services in Russia

Emergo Group assists medical device and IVD companies with obtaining approval to sell their products in the Russian Federation. The consulting services we offer are shown below.

Medical Device Registration in Russia

The Russian process for medical device registration  is complicated and a local presence in Moscow is essential for successful registration of devices. We can assist in the preparation of documentation, translations and meetings with Roszdravnadzor to ensure a successful submission.

GOST-R Certificates

A GOST-R certificate is similar to the CE Marking certificate and is required for most medical devices in Russia. We can prepare the necessary documents and coordinate testing required to obtain your GOST certificate.

Sanitary-Epidemiological Conclusion (Hygiene Certificate)

Products that come into contact with the skin must obtain a Hygiene Certificate before they can be imported into the Russian Federation. We can help you obtain this certificate.

Click on the image to download this PDF of the medical device approval process in Russia